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Patent Application 18855563 - INTRANASAL ADMINISTRATION OF N-ACETYLCYSTEINE - Rejection

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Patent Application 18855563 - INTRANASAL ADMINISTRATION OF N-ACETYLCYSTEINE

Title: INTRANASAL ADMINISTRATION OF N-ACETYLCYSTEINE AND USES THEREOF

Application Information

  • Invention Title: INTRANASAL ADMINISTRATION OF N-ACETYLCYSTEINE AND USES THEREOF
  • Application Number: 18855563
  • Submission Date: 2025-05-21T00:00:00.000Z
  • Effective Filing Date: 2024-10-09T00:00:00.000Z
  • Filing Date: 2024-10-09T00:00:00.000Z
  • Examiner Employee Number: 79521
  • Art Unit: 1691
  • Tech Center: 1600

Rejection Summary

  • 102 Rejections: 0
  • 103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

Office Action Text


    Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
			Priority and Status of the Claims
1.	This application is a 371 of PCT/US2023/012538 02/07/2023, which claims benefit of the provisional application: 63307260 with a filing date 02/07/2022.
2. 	Claims 1-46 are pending in the application.  
Claim Rejections - 35 USC § 112
3.	The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a)  IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

3.1 	Claims 1-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph (pre-AIA ), because the specification does not reasonably provide enablement for the instant “a therapeutic agent” and “a congener” without limitation (i.e., no named compounds), see claims 1-46.  The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. 
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described. They are:
1.    the nature of the invention,
2.    the state of the prior art,
3.    the predictability or lack thereof in the art,
4.    the amount of direction or guidance present,
5.    the presence or absence of working examples,
6.    the breadth of the claims,
7.    the quantity of experimentation needed, and
8.    the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is methods of use using compositions comprising “a therapeutic agent” and “a congener”, wherein the “a therapeutic agent” and “a congener” are without limitation, see claims 1-46
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is Greene et al. US 12,090,130.  Greene et al. ‘130 discloses a congener glutathione, see claim 12 in column 56.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is the description of a number of “a therapeutic agent” and “a congener” on pages 4-6 of the specification. There is no data present in the instant specification for the instant “therapeutic agent” and “a congener” without limitation (i.e., no named compounds).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant “a therapeutic agent” and “a congener” are without limitation (i.e., no named compounds).
The quantity or experimentation needed and the level of skill in the art
While the level of the skill in the chemical arts is high, it would require undue experimentation of one of ordinary skill in the art to resolve any instant “a therapeutic agent” and “a congener” without limitation. There is no guidance or working examples present for constitutional any instant “a therapeutic agent” and “a congener” without limitation for the instant invention. Incorporation of the limitation of the instant “a therapeutic agent” and “a congener” (i.e., claims 4, 14-20 and 35) supported by the specification into claims 1 and 23 respectively would overcome this rejection.
3.2	Claims 1-46 are rejected under 35 U.S.C. 112, first paragraph (pre-AIA ), because the specification does not reasonably provide enablement of “disease or disorder” without limitation (i.e., no named diseases or disorders), see claims 1-46.  The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.

In the instant case:
The nature of the invention
The nature of the invention of claims 1-46 is drawn to intent methods of use for  treating disease or disorder without limitation (i.e., no named diseases or disorders).   
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in
vitro and in vivo to determine which compound iloperidone exhibit the desired pharmacological activities (i.e., what compound iloperidone can treat which specific diseases by what mechanism). There is no absolute predictability even in view of the seemingly high Ievel of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.  The prior art is Greene et al. US 12,090,130.  Greene et al. ‘130 discloses methods of use for treating concussion using 
N-acetylcysteine, see column 55.

The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each
embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833,166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. 
	Applicants are claiming intent methods of use using the instant 
“disease or disorder” without limitation (i.e., no named diseases or disorders).   As such, 
the specification fails to enable the skilled artisan to use the “disease or disorder” without limitation (i.e., no named diseases or disorders).    In addition, there is no established correlation between in vitro or in vivo activity and accomplishing “disease or disorder” without limitation (i.e., no named diseases or disorders), and those skilled in the art would not accept allegations in the instant specification to be reliable predictors of success, and those skilled in the art would not be able to use the instant compound 
since there is no description of an actual method “disease or disorder” without limitation 
(i.e., no named diseases or disorders) in a host is treated.
	Hence, one of skill in the art is unable to fully predict possible results from the 	 	            administration of the instant compound due to the unpredictability of 	 	   			 	“disease or disorder” without limitation (i.e., no named diseases or disorders). The 
“Disease or disorder” without limitation (i.e., no named diseases or disorders) is known 
to have many obstacles that would prevent one of ordinary skill in the art from accepting 
treating regimen on its face.

The amount of direction or guidance present and the presence or absence of working examples
	The only direction or guidance present in the instant specification is the 		   	              description of treating a number of disorders, see pages 14-17 of the specification.   
  There are no in vitro or in vivo working examples present for “disease or disorder” 
   without limitation (i.e., no named diseases or disorders) by the administration of the 
    instant invention.  
The breadth of the claims
	The breadth of the claims is methods of use of the instant compound for 	  	   	              “disease or disorder” without limitation (i.e., no named diseases or disorders).
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in 
the art would need to determine how “disease or disorder” without limitation (i.e., no 	  	            named diseases or disorders) would be benefited (i.e., treated) by the administration of 
the instant invention and would furthermore then have to determine which of the 
claimed methods of use would provide “disease or disorder” without limitation (i.e., no 		            named diseases or disorders), if any.
The Ievel of the skill in the art 
The Ievel of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by successful conclusion'' and ''patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable''.
in vitro and in vivo screening to determine which methods of use exhibit the desired pharmacological activity and which would benefit from this activity. Thus, the specification fails to provide sufficient support of the broad use of the pharmaceutical composition of the instant claims for the various diseases or disorders. 
As a result necessitating one of skill to perform an exhaustive search for which metabolic-related disease s can be treated by what pharmaceutical compound of the instant claims in order to practice the claimed invention. Thus, factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compound regards to the treatment of the many diseases, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Genentech lnc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “ a
patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion'' and ''patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable''.
	Therefore, in view of the Wands factors and ln re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation, with no assurance of success.  This rejection can be overcome by incorporation of named diseases or disorders supported by the specification (i.e., claims 25-35) into claims 1 and 23 respectively would obviate the rejection. 
4.        The following is a quotation of 35 U.S.C. 112(b):

(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.



Claims 5-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA  the applicant regards as the invention.
Claims 5-12 independently recite the limitation “the dose” without naming particular active ingredient is ambiguous and indefinite. Clarification is required.
5.	In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103

6. 	The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.


The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
	2. Ascertaining the differences between the prior art and the claims at issue.
	3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating   
    obviousness or non-obviousness.
This application currently names joint inventors.  In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1 and 23 are rejected under 35 U.S.C. 103(a) as being obvious over Ratan et al. US 2018/0344678 A1 and Hornstein’s US 2013/0184316 A1.
	Applicants claim a method comprising administering to a subject in need thereof: a) a dose of a compound, wherein the compound is N-acetylcysteine (NAC) or a pharmaceutically-acceptable salt or congener thereof, and b) a therapeutically-effective amount of a therapeutic agent, wherein the administering delivers the therapeutic agent to a brain tissue of the subject in an amount that is at least about 20% greater than an amount of the therapeutic agent delivered to the brain tissue of the subject when administered without the dose of the compound, see claim 1.
	Applicants claim a method of treating a brain disorder in a subject in need thereof, the method comprising intranasally administering to a nose of the subject: a) a dose of a compound, wherein the compound is N-acetylcysteine (NAC) or a pharmaceutically-acceptable salt or congener thereof; and b) a therapeutically-effective amount of a therapeutic agent, see claim 23.
Determination of the scope and content of the prior art (MPEP §2141.01)
	Ratan et al.  ‘678 discloses a 5-lipoxygenase activating protein (FLAP) inhibitor selected from N-acetylcysteine (NAC) or glutathione (i.e., a congener) for treating brain disorder concussion, see section [0052], [0056] and [0189] in columns 3 and 15, and claims 1 and 4 in column 16.
       		Hornstein’s ‘316 discloses a therapeutic agent mono- or di-aminopyridine for 
             treating brain disorder concussion in a subject, see claims 1 and 3 in column 18.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims Ratan et al.  ‘678 and Hornstein’s ‘316 is that the instant claims are embraced within the scope of Ratan et al.  ‘678 and Hornstein’s ‘316.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1 and 23 prima facie obvious because one would be motivated to employ the methods of use of Ratan et al.  ‘678 and Hornstein’s ‘316 to obtain instant invention.
                        It is prima facie obvious to combine teachings from Ratan et al.  ‘678 and 
            Hornstein’s ‘316 which provide N-acetylcysteine (NAC) or glutathione (i.e., a congener) 
            and a therapeutic agent , each of  which is taught by the prior art to be useful for the 
           same purpose, i.e., for treating brain disorder, to be used for the very same purpose. 
           Therefore idea of combining them flows logically from theirs having been individually 
            taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 
            (CCPA 1980), see MPEP 2144.06.  
							                      Moreover, the amount of a specific amount of ingredient N-acetylcysteine (NAC) 
           or glutathione (i.e., a congener) and a therapeutic agent of the instant composition and 
          methods of use is clearly a result effective parameter that a person of ordinary skill in the 
          art would routinely optimize, optimization of parameters (dose, and administration 
           strategy) from known compositions and methods of use of Ratan et al.  ‘678 and 
           Hornstein’s ‘316 is a routine practice  that  would be obvious for a person of ordinary skill 
           in the art to employ and reasonably would expect success. It would have been customary 
           for an artisan of  ordinary skill to determine the optimal amount of each ingredient to add 
           in order to best achieve the desired results based on factors such as the severity of the 
           condition being  treated for cystic fibrosis diseases. Therefore of Ratan et al.  ‘678 and 
           Hornstein’s ’31 render obviousness over the instant invention.
           The motivation to make the claimed methods of use derived from the known 
compositions and methods of use of Ratan et al.  ‘678 and Hornstein’s ‘316
would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707.  The examiner can normally be reached on 8:30 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394.  The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system.  Status information for published applications may be obtained from either Private PAIR or Public PAIR.  Status information for unpublished applications is available through Private PAIR only.  For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.








/REI TSANG SHIAO/



Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691      

                                                                                                                                                                                                  
May 19, 2025


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