DETAILED ACTION
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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 06/27/2024, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim and Specification Objections - Sequence Compliance
Claim 1 and Specification are objected to because of the following informalities: 37 CFR 1.821(d) states that where the claims/Specification recite a sequence the sequence identifier must be included. The applicants have provided a sequence listing, but have not included the corresponding sequence identifiers in claim 1 and in pages 3, 7 and 14 of Specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-9 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 6-7 recite term ‘product’ in the claim language, whereas independent claim does not have this limitation. There is insufficient antecedent basis for this limitation in the claim. Accordingly claims 6-7 and their dependents are rendered indefinite.
Claim Rejections - 35 USC § 112 – Written Description
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 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for the claimed method. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is based on the requirement(s), i.e., the guidelines provided by the MPEP 2163.04. These are listed below:
(A) identify the claim(s) limitations at issue, and
(B) establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. The MPEP 2163 further provided or expanded the guidelines for the written description requirements.
(A) IDENTIFY THE CLAIM LIMITATIONS AT ISSUE:
Independent claim 1 is drawn to a method for preventing or treating skin injury diseases, comprising administering to a patient a polypeptide, wherein the polypeptide is Pro-Ala- Ala-Glu-Pro-Val-Pro-Leu or a physiologically compatible salt thereof.
Above claimed subject matter prevents and treats all possible skin injury diseases in all possible humans and non-humans, by administering the recited peptide in all possible mode of administrations, wherein administration can be any known mode of administration.
The claimed term “skin injury diseases” is not art recognized terminology. It is interpreted as ‘skin injury caused by diseases’, and/or ‘injury followed by an infection or disease’, such as bacterial infection, skin burn followed by infection etc.
The term “preventing”, according to Merriam-Webster’s Online Dictionary defines it as “to keep from happening or existing”., i.e., to completely eradicate. So, claimed subject matter is drawn to completely eradicating all possible skin injury diseases, both existing and from the future occurrences. It is presumed “prevention” of the claimed skin injury diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. Also, instant specification provides no limiting definition of the term “preventing”.
Dependent claims further limit skin injury to the recited divergent sub-genus species and the property of the polypeptide. Some of the skin injuries are external and some are internal of the body. Some of the recited species are not diseases. For example, wounds and ringworms are not diseases. No dosage amounts are cited in the claims.
It the above claims other than polypeptide all are variables, and none of the claims limit these variables into specific species.
To support above broadly claimed subject matter, specification exemplified or described, in examples 2 and 3, effect of the polypeptide on the healing of skin ulcers in diabetic mouse model and acute mechanical skin injuries in rats. In examples 4-7, specification describes effect of polypeptide in the recited cell lines and concluded that the observed end property involved in the wound healing. In examples 8 and 9, effect of polypeptide in promoting tissue regeneration and angiogenesis in zebrafish are shown. In examples 10 and 11, the shown data is the healing effect of the polypeptide on skin ulcer in diabetic rats, and on full-layer skin defect wound in SD rats.
As explained above, the shown data is limited ulcer and expression levels of wound healing markers in the shown cell lines. However, there is description on ‘how the shown data is extrapolated to prevent and treat all possible skin injury diseases’?
So, the issue is in the scope of the broadly claimed subject matter and specification failed to describe the nexus between the shown data and broadly claimed subject matter. In other words, the structure/function relationship for the claimed generic variables and claimed method is not described.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a divergency in the broadly claimed subject matter, and if it expects unpredictability for the claimed method, then specification must describe the genus with divergent species, so that a skilled person in the art can understands claimed invention and can reproduce applicants claimed method. The absence of description with divergent species makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure. See MPEP 2163 II(A)(3)(a)(ii).
The number of species that describe the genus must be adequate to describe the entire genus. However, if there is substantial variability, a large number of species must be described.
The question is Above claimed subject matter prevents and treats all possible skin injury diseases in all possible humans and non-humans, by administering the recited peptide in all possible mode of administrations, wherein administration can be any known mode of administration.
The question is with several hundreds of possible skin injury diseases (i) did applicants provide enough description for preventing and treating all possible skin injury diseases with all possible mode of administrations? (ii) is shown data in cell lines capable of retain its property in all types of cell lines? Based (i) and/or (ii), will a skilled person in the art understand the claimed invention?
(B) ESTABLISH A PRIMA FACIE CASE BY PROVIDING REASONS WHY A PERSON SKILLED IN THE ART AT THE TIME THE APPLICATION WAS FILED WOULD NOT HAVE RECOGNIZED THAT THE INVENTOR WAS IN POSSESSION OF THE INVENTION AS CLAIMED IN VIEW OF THE DISCLOSURE OF THE APPLICATION AS FILED:
The further analysis for adequate written description considers, see MPEP 2163, the following:
(A) Determine whether the application describes an actual reduction to practice of the claimed invention:
Not provided. The claimed preventing and treating all possible skin injury diseases is speculative in light shown data in the specification. Cell lines and type of injury or wound are divergent. For example, cell lines in the eye are totally different from that of cell lines involved in ulcer or heart.
Accordingly, applicants failed to describe actual reduction to practice of the claimed invention.
(B) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole:
Fig.1-4 describes proliferating-promoting effect of the polypeptide on HaCaT, HMEC-1, Balb-3T3 and RSC96 cell lines.
Fig.5-7 describes effect of the polypeptide zebrafish caudal fin regeneration, regeneration of blood vessels in zebrafish.
Fig.8 describes effect of polypeptide on the formation rate of new granulation tissues in STZ induced diabetic rats.
However, no description or nexus between the shown data in figures and claimed preventing and treating skin injury diseases.
So, as evidenced from the above description of drawings, it is clear that the claimed invention is not complete by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole.
(C) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics, such as structure/function correlations, as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention:
While the state of the art is relatively high with regard to treating wounds and skin injuries diseases, but the state of the art with regard to “prevention” of such diseases is underdeveloped. In particular, there do not appear to be any examples or teachings in the prior art wherein applicants claimed peptide or structurally similar peptides was administered to a subject to provide prevent skin injury diseases. In fact, there is no cure for some of skin injury diseases and also some uncertainties in the treatment methodologies.
For example, Teasdale [British Journal of Dermatology (2021) 184, pp627–637] states that effective self-management of eczema could be supported by addressing beliefs and concerns about treatments; seeking positive ways to promote a ‘control not cure’ message; acknowledging psychosocial impacts of eczema and treatment burden; and providing clear consistent advice or signposting towards reliable information [see page 627]. There are also uncertainties in treating eczema.
There are also uncertainties in treating dermatitis related diseases and wounds etc. See the established facts from the following art:
Teasdale [British Journal of Dermatology (2021) 184, pp627–637] also states that many studies reported common concerns, doubts and perceived difficulties around eczema treatment, reflecting an implicit caution and uncertainty about topical treatments, particularly topical corticosteroids, and a general hesitancy towards regular or long‐term treatment. This hesitancy seemed to be exacerbated by having received negative or conflicting advice about topical treatments from health professionals and significant others. [see page 634].
Lax [Clinical & Experimental Allergy, 2024, 54, 960-972] states that eczema is the most burdensome skin condition worldwide and topical anti-inflammatory treatments are commonly used to control symptoms. The relative effectiveness and safety of different topical anti-inflammatory treatments is uncertain [see abstract]. The skin condition is interpreted as skin injury disease, which reads applicants subject matter.
Eckert [Wound Rep Reg, 2021, 29, 327–334] describes uncertainties in the treatment of venous leg ulcer [see abstract].
Velickovic [Int Wound J, 2023, 20, 792–798] describes uncertainties in treating wounds.
There is also unpredictability in the mode of administration, for example, Bruno [Ther Deliv, 2013 Nov, 4(11), 1443-1467] teach the following:
While the peptide and protein therapeutic market has developed significantly in the past decades, delivery has limited their use. Although oral delivery is preferred, most are currently delivered intravenously or subcutaneously due to degradation and limited absorption in the gastrointestinal tract. Therefore, absorption enhancers, enzyme inhibitors, carrier systems and stability enhancers are being studied to facilitate oral peptide delivery. Additionally, transdermal peptide delivery avoids the issues of the gastrointestinal tract, but also faces absorption limitations. Due to proteases, opsonization and agglutination, free peptides are not systemically stable without modifications. This review discusses oral and transdermal peptide drug delivery, focusing on barriers and solutions to absorption and stability issues. Methods to increase systemic stability and site-specific delivery are also discussed. [See abstract and whole article].
In view of above evidences, applicants have claimed wide range of skin injury diseases and a skilled person in the art can expect unpredictability in the broadly claimed subject matter. There are no physical/chemical/structural features that applicants have tied to this property in a relevant teaching manner, making it impossible for an individual of ordinary skill in the art to determine which of the very large genus of diseases would be treated effectively. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.
Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure species to make and possibly use of the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 9 of US 12,351,651 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Claims of instant application are drawn to a method for preventing or treating skin injury diseases, comprising administering to a patient a polypeptide, wherein the polypeptide is Pro-Ala- Ala-Glu-Pro-Val-Pro-Leu or a physiologically compatible salt thereof, wherein skin injury disease comprises wounds, ulcers, dermatitis etc.
Claims of US patent are drawn to a polypeptide, for example SEQ ID NO:6, which is identical to applicants polypeptide, and its utility in treating or repairing skin wounds, ulcers etc. [see claim 1, 4 and 9].
Difference is that claims of US patent are broader in scope, whereas claims of instant application are narrower in scope with the recited species.
So, scope of claimed subject matter overlaps and the claimed subject matter of instant application is fully disclosed in the patent and is covered by the patent. The difference, however, does not constitute a patentable distinct, because a skilled person in the art would be motivated to extrapolate the utility of polypeptide to the nearest wound related injuries, and therefore instant claims are not patentably distinct from the claims of US patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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