CLAIMS 1-13, 17-20, 22, 24 AND 25 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s Preliminary Amendment filed May 23, 2023 and Information Disclosure Statements filed May 23, 2023 and February 01, 2024 have been received and entered into the application. Accordingly, the application papers have been amended as directed. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
Claim Rejection - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-7, 9-13, 17-20, 22, 24 and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the prevention or treatment of infectious keratitis, oral thrush, trench mouth, and herpes simplex virus-1 infection, (i.e., the subject matter of present claim 8), does not reasonably provide enablement for the prevention or treatment of “infections” in general, i.e., each and every type of known infection caused all known pathogenic bacteria, viruses, fungi and/or parasites. 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 and use the invention commensurate in scope with these claims.
Suggestion for Overcoming the Present Rejection
Applicants may wish to consider amending the independent claims to incorporate the subject matter of claim 8.
Support for Rejection
In regards to the present rejection, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) Nature of invention;
2) State of the art;
3) Level of ordinary skill in the art;
4) Level of predictability in the art;
5) Amount of direction and guidance provided by the inventor;
6) Existence of working examples;
7) Breadth of claims; and
8) Quantity of experimentation needed to make or use the invention based on the content
of the disclosure.
The relevant factors are addressed below on the basis of comparison of the disclosure, the
claims and the state of the prior art in the assessment of undue experimentation.
1) Nature of the invention.
The claims are directed to preventing or treating an infection in general or to a microbial, viral, bacterial or parasitic infection at the most, (present claims 2-3), (hereinafter “treatment” in general).
2) State of the art.
While it is axiomatic that the state of the art is relatively high with regard to the treatment of specific types of infections with a particular active agent or combinations thereof, the state of the art with regard to treating “infection” broadly with a particular active agent or combination of active agents would be deemed underdeveloped, i.e., the premier anti-infective “panacea” has yet to be identified in such a manner to be known by and/or in possession of the public. Indeed, the Examiner has conducted a comprehensive search of a plethora of the appropriate electronic data bases and cannot find any credible example of a particular active agent, or combination of different active agents indicated for the treatment of all known types of infection reported in the literature.
3) Level of ordinary skill in the art.
The level of ordinary skill in the art is high and would include the skill possessed by a person holding at least a doctor of medicine degree. However, given the above discussion, the artisan is currently unaware of any one particular anti-infective agent, whether it be a single active agent or a combination of actives, which is/are effective in treating “infection” in general, i.e., all known types of infections.
4) Level of predictability in the art.
The lack of significant guidance from the present specification or any art of record with regard to the treatment of all types of infection with a single active agent or combination of actives imparts a significant degree of unpredictability in practicing the invention as presently claimed.
5) Amount of direction and guidance provided by the inventor.
The guidance given by the specification is to generally administer the claimed active
agent combinations to treat “infections” in general as well as to treat particular types of cancers as set forth in present claim 8 for which enablement is deemed present.
6) Existence of working examples.
All narratives and data depicted in Applicant’s specification, including the drawings, are directed to results showing upregulation of human p3-defensin 3 observed using the claimed active agents. Such would be significantly incapable of providing an objective foundation supporting a proposition that the claimed active agent combinations would be effective for the treatment of all types of infections.
7) Breadth of claims.
The complex nature of the subject matter to which the present claims are directed is
exacerbated by the breadth of the claims. The claims are unduly broad because of the vast number of specific and diverse conditions represented by the term “infection”.
8) Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification does not enable any person skilled in the art to which it pertains to make or use the invention commensurate in scope with this claim. Applicant has failed to provide guidance and information to allow the skilled artisan to ascertain that the present active agents, alone or in combination with other actives, are effective against all known types of infection. The limited enablement for the specifically named infections claim 8is noted, but does not support a claim for the treatment of all types of infection.
Further Burden on the Examiner for Making a Rejection Under 35 U.S.C. § 112 First Paragraph
As set forth in In re Marzocchi, 169 USPQ 367, 370 (CCPA 1971):
“[A] [s]pecification disclosure which contains teaching of manner and process of making and using the invention in terms corresponding to the scope to those used in describing and defining subject matter sought to be patented must be taken as in compliance with enabling requirement of first paragraph of 35 U.S.C. 112 unless there is reason to doubt the objective truth of statements contain therein which must be relied on for enabling support; assuming that sufficient reason for such doubt exists, a rejection for failure to teach how to make and/or use will be proper on that basis, such a rejection can be overcome by suitable proofs indicating that teaching contained in specification is truly enabling.” (emphasis added).
Here, the objective truth of the statement that infections of a non-restricted nature could each be successfully treated with any active agent, or combination of active agents, is doubted because it appears that while it is recognized that certain types of infections respond to a particular active agent or combination thereof, the art is apparently unaware of any anti-infective “panacea”-type agent or combination of agents. Given this, the proposition that all known types of infection could be treated with a particular active agent or combination thereof is but an unsubstantiated possibility and not a treatment outcome that could be accomplished with a reasonable degree of certainty or without a burden of undue experimentation, i.e., determining for which, from among all known infection types, the particular types of infections the claimed composition could treat besides those of present claim 8.
Summary
As the discussion above points to, practicing the claimed method in the manner disclosed by Applicant would not imbue the skilled artisan with a reasonable expectation that infections of all types could be effectively treated with the presently claimed formulations. In order to actually achieve the claimed objective, if at all possible, it is clear from the discussion above that the skilled artisan could not rely on Applicant' s disclosure as required by 35 U.S.C. § 112, first paragraph. Given that the art is unaware of or fails to recognize, and Applicant has failed to demonstrate sufficient evidence to establish, that all known types of infection could actually be treated in the manner claimed, the skilled artisan would be faced with the impermissible burden of undue experimentation in order to practice this embodiment of the claimed invention.
Accordingly, claims 1-7, 9-13, 17-20, 22, 24 and 25 are deemed properly rejected.
Claim Rejection - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 12, 17 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 101049312 B to Huang (using the English language document submitted by Applicant, hereinafter “Huang”).
Huang discloses a method of treating or preventing an infection (Abstract composite medicine for treating various bacterial and viral Infections is prepared; Pg. 3 Para 5, invention provides a kind of pharmaceutical compositions against all kinds of responsive viruses and responsive germs of the respiratory tract) comprising administering to a subject in need thereof (Pg. 3 Para 16, Preparation of the present Invention. optimizing injection. more preferably injectable sterile powder…3 external…spray, drop i.e., compare to claim 24) an effective amount of a andrographolide compound (Pg. 3 Para 4 present invention is to provide a kind of pharmaceutical composition, this pharmaceutical composition is made up of andrographolide, cephalosporins and pharmaceutically acceptable auxiliaries).
Eye infections as well as mucosal membrane health promotion are fairly taught above where the treatment of eye infections is clearly taught and where respiratory tract infections are taught, mucosal membrane health promotion would necessarily be involved. To the extent that an infected cornea or other eye surface can be considered an eye “wound”, claims 12 is properly included here.
While corneal infections, i.e., infectious keratitis, is not specifically disclosed, given the limited genus of eye structures subject to infections, the disclosure of eye infections by Huang is deemed sufficient to be anticipatory for each specific structure, e.g., the cornea, which could be infected and treated via the method of Huang.
Claims 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0193139 A1 to National Dong Hue University (hereinafter “Dong”).
Regarding claim 12, Dong discloses a method of treating a wound (Para [0003] composition and method for wound healing, especially, for composition having Andrographis penlculata derivatives) comprising administering to a subject In need thereof, (Para [0017] [t]he present invention also provides a method for wound healing and/or skin whitening, comprising: administrating the aforesaid pharmaceutical composition), an effective amount of a compound selactad from the group consisting of andrographolide…, (Para [0010] a pharmaceutical composition for wound healing and/or skin whitening, comprising: 0.01 to 1 wt% of an active ingredient, comprising an Andrographis paniculeta extract, Andrographolide).
Regarding claim 13, Dong discloses the method of claim 12, at [0016], where it is set forth that preferably, said wound is a burn wound.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10, 12, 17-19, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over CN 101049312 B to Huang OR claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0193139 A1 to Dong, each as above under 35 U.S.C. 102, for the reasons set forth above which are here incorporated by reference in view of WO 2006/008115 to Martin Körber, (hereinafter “Körber”, cited by Applicant).
The difference between the above and the claimed subject matter lies in that neither Huang or Dong teach the presently claimed derivatives of andrographolide. Also, Huang fails to teach the nebulization of the composition for the treatment of the respiratory infections.
However, 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 because the primary references each teach Andrographolide as the active agent for treating the various infectious conditions and, as taught by Körber, not only is andrographolide, itself, useful for these purposes, various androgrpholide derivatives were also known to be as useful, (see at least the abstract and claim 1). Thus, one of ordinary skill in the art would have been motivated to use the derivative compounds in place of the parent compound as all such compounds were known as therapeutic alternatives.
Also, Huang teaches administration in general for the treatment of respiratory infections and thus would have conveyed to one of ordinary skill in the art each known route/mean of administration including inhalation of a fine particulate composition, i.e., nebulization.
None of the claims are currently deemed allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 December 03, 2025