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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 4-5, 8-11, and 13-14 and species: PSG1, lung cancer, siRNA, monoclonal antibody, immunotherapy, immune checkpoint inhibitor therapy, an anti-PD-1 antibody, tumor-infiltrating lymphocyte therapy as the adoptive cell therapy type, interferon alpha as the cytokine, intravenous administration, immunostaining, and tumor tissue in the reply filed 03/26/2026 is acknowledged.
Upon further consideration, the Examiner is withdrawing the species requirement for type of cancer. As such, all cancer types listed in the claims are now under examination.
Claims 15-17, 19-25 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 03/26/2026.
Claims 1-2, 4-5. 8-11, and 13-14 are now under consideration in the instant Office Action.
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.
Claim 2 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Instant claim 2 recites the term “optionally”. The phrase “optionally” is interpreted as "for example" which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purposes of examination, the instant claims will be interpreted without the optional limitations as they are not required or claimed as necessary to the invention.
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 1-2, 4-5 8-11, and 13-14 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. 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See MPEP §2163(I)(A) which states: "The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Claim 1 calls for a pregnancy specific glycoprotein (PSG) inhibitor that functions in a method for treating cancer. There is no specific structural requirement for the PSG inhibitor beyond the required function. Claim 9 calls for an immunotherapy treatment which comprises the PSG inhibitor and an immune checkpoint inhibitor, but fails to describe the structure for each of the components. Instead, the instant claims list a number of species of antibodies but does not require any specific structure or function for any species within this list of antibodies. The required function of the inhibitor and immune checkpoint inhibitor therapy can be achieved in any form, no specific structure is required, as long as they function in a method of treating cancer. The scope of the claim is so broad and reads on so many possible genera that it is clear that the specification fails to describe all of the possible means of achieving the response linked to its function. The claims do not require that any of the PSG inhibitors possess any particular conserved structure or other disclosed distinguishing features. Therefore, the genera are merely defined by function and the instant specification fails to describe the full genera of the possible methods that are encompassed by these claims.
There is no structural requirement for the claimed PSG inhibitors and antibodies beyond function. The narrowed list of target sites for the PSG inhibitor in instant claim 2 does not even have a functional requirement; it only describes which antigen site or gene the PSG inhibitor can potentially bind to. The claimed activity of the PSG inhibitors and antibodies can be achieved in any form as long as the they provide the specifically claimed function. Further, compounded by the limitation of the variants of the PSG inhibitor and antibodies, it is unclear what would meet the requirements for cancer treating. Instant claims 8-11 recite a wide variety of combination treatments that include the PSG inhibitor of claim 1; however, these limitations are generic and undefined and the instant specification does not provide adequate written description for these limitations. For example, instant claim 9 describes several genera of antibodies without a particular structure to define their identities. Applicant has not provided adequate disclosure in the specification of the combination treatments recited in the instant claims, nor have they provided details regarding the various components that are to be included in the claimed method.
There are a few specific examples of PSG inhibitors in the instant specification, but there is no support provided that the applicants have envisioned all of the possible variants encompasses by these functional requirements of the instant claims. The instant claims do not require that the claimed agents possess any particular conserved structure or other disclosed distinguishing feature. The scope of the terms of the “inhibitor” is so broad and reads on so many possible genera and the instant specification fails to describe any of the possible inhibitors that are encompassed by this term. The claims do not require that the “inhibitor” possess any particular conserved structure or other disclosed distinguishing feature. The term “inhibitor” encompasses many things including antibodies, antisense oligonucleotides, a sgRNA, a shRNA, a siRNA, an aptamer, a ribozyme, an antibody agent, or a small molecule inhibitor as long as they achieve the required function. Thus the claims are drawn to multiple genera of molecules that are defined only by they function as an immunosuppressive agent. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of molecules that are encompassed by this claim.
To provide adequate written description and evidence of possession of claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of prospective activity or function. There is not even identification of any particular portion of the structure that must be conserved for said activity except its function. The specification does not provide a complete structure of all possible forms of the claimed inhibitor and variants and fails to provide a representative number of species for any genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genera of PSG inhibitors and antibodies.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “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 they invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed structure of the encompassed agents, fragments and variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claims 1-2, 5, 8-11, and 13-14 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 a method of treating cancer that overexpresses PSG using an anti-PSG antibody disclosed on page 54 of the instant specification, does not reasonably provide enablement for a method of treating any cancer using any PSG inhibitor and any antibody. 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.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to this rejection are 1) the amount of direction provided by the inventor, 2) the existence of working examples, and 3) undue experimentation. In the instant case, the amount of direction provided by the inventor, undue experimentation, and existence of working examples disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
(1) The amount of direction provided by the inventor - The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in treating cancers using undefined inhibitors of PSG and undefined antibodies, the skilled artisan would need significant guidance in preparing a combination immunotherapy treatment with a targeted function of treating cancer. The skilled artisan recognizes that antibody binding is a wildly unpredictable endeavor that requires specificity in structure when targeting antigens. Without a proper structure provided by the Applicant for the invention(s), it is nearly impossible to envision and recognize all the potential structures amongst all potential possibilities of antibodies and inhibitors that would have a structure capable of binding, in addition to possessing the functionality needed to access it as a treatment for any and all cancers as claimed.
(2) The existence of working examples - As stated above the specification reasonably provides enablement for an anti-PSG antibody disclosed on page 54; however, there is no showing in the specification of any means by which one skilled in the art could prepare any antibody or inhibitor against PSG to treat any cancer. Additionally, more information would be needed to ascertain how the PSG inhibitor would be able to work on cancers that do not overexpress PSG as is recited in the instant claim, which encompasses any and all types of cancers without limitation. Applicant provides examples in the instant specification of using the disclosed antibodies as a treatment against cancers which overexpress PSG, but falls short to provide support for how any undefined antibody or inhibitor to PSG as recited in the instant claims can achieve the same function given that their structures have not been defined.
(3) Undue experimentation – The instant claims cover all possible antibodies and inhibitors to PSG as long as they are capable of being used in a method to treat cancer. Further, these claimed antibodies and inhibitors encompass any possible future discoveries of any factors and substances with the claimed functions. When claims depend on a recited property (inhibiting a certain pathway), a fact situation comparable to Hyatt is possible, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor. See also Fiers v. Sugano, 984 F.2d 164, 25 USPQ2d 1601 (Fed. Cir. 1993) and MPEP §2164.08(a). Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the instant method except for the instant examples, thereby requiring trial and error experimentation to identify compounds meeting the functional limitations of the claims.
As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the instant method, thereby requiring trial and error experimentation to identify antibodies or recombinant proteins meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor, undue experimentation, and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4-5, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shanghai et al. 2002 (WO/0206475 A1, in IDS filed 11/11/2022), in view of Salahshor et al. 2005 (in IDS filed 11/11/2022).
Shanghai et al. teaches a method for treating cancer in a subject in need thereof comprising polypeptides, antagonists, agonists and inhibitors of the polypeptide that can be directly used for treatment of cancers, see paragraphs [0082], [0094], [0106]-[0107], comprising administering to the subject a therapeutically effective amount of at least one pregnancy specific glycoprotein PSG inhibitor, see paragraph 0128. This meets the limitations of instant claims 1 and 2 wherein a PSG inhibitor is used in a method for treating a cancer that overexpresses one or more PSG genes, instant claim 5 wherein an inhibitor of the PSG gene is used, and instant claim 14 wherein the use of the PSG inhibitor improves the subject’s condition.
Shanghai et al. teaches that the disclosed antibodies which specifically bind to the pregnancy specific glycoprotein beta 1 epitopes are intended for treating a disease associated with pregnancy specific glycoprotein beta 1, and can be administered in appropriate dose for blocking the pregnancy-specific glycoprotein production; see Abstract and paragraphs 0048 and 0115. This meets the limitations of instant claim 1 wherein an antibody is used as an inhibitor of PSG and instant claim 2 wherein the PSG gene subtype that is overexpressed is PSG1. Shanghai et al. also teaches that the pharmaceutical compositions can be administered intravenously. This meets the limitations of instant claim 13 wherein the inhibitor is administered intravenously.
However, Shanghai does not disclose a tumor that overexpresses PSG gene. Salahshor et al. remedies this deficiency.
Salahshor et al. discloses a tumor that overexpresses the PSG gene, see wherein “the pregnancy specific glycoprotein 9 is upregulated in vivo by cancer cells in colorectal cancer”; see Abstract. Salahshor et al. also discloses that the cancer is colon cancer or rectal cancer, see “pregnancy specific glycoprotein 9 is upregulated in vivo by cancer cells in colorectal cancer with multiple colonic adenomas, northern blot showed clear expression of three PSG9 transcripts in colon and rectal cancer” in Abstract and page 7, second column, first paragraph. This meets the limitations of instant claim 4 wherein the cancer is a colon or rectal cancer.
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method as previously disclosed by Shanghai, which teaches the use of a PSG inhibitor as a treatment against cancers that express PSG, with the teachings of Salashor et al., which teach the overexpression of PSG subtypes on particular cancer cells. One would be motivated to combine the references with the expectation that providing additional information on the direction of alteration of the gene expression of PSG gene in cancer cells would provide for a more targeted and successful approach when treating cancers marked by the overexpression of PSG.
Therefore, claims 1-2, 4-5, and 13-14 are rejected as obvious over Shanghai et al. and Salahshor et al.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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