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 .
Status of the Application
Claims 1-70 are pending.
Election/Restrictions
Applicant's election without traverse of Group I, claims 36-70, directed to ent-19-norprogesterone and a composition comprising the same in the reply filed on 08/04/2026 is acknowledged.
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Although the response is a noncompliant response to the office action as applicant withdrew all claims that were restricted and entered new claims, the response was considered for compact prosecution. Election to claims 36-70 is considered final.
The requirement is still deemed proper and is made FINAL.
Claims 1-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claims 36-70 are under current examination.
Claim Objections
Claims 64, 65, 68, 69 are duplicate claims and claims same subject matter as claim 36.
Claim 65 is also objected as the claim is missing period at the end of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 36, 37, 40-70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a naturally occurring compound ent-19-norprogesterone that naturally exist in in human/ animal body along with its other isomers, stereoisomers, water, enzymes, proteins etc. (i.e., composition), as evidenced in the instant specification paragraphs 0018-0021 (published instant application):
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Or as evidenced by Casey (J. Clin. Invest. Vol 75, 1985, 1335-1338) (entire article, especially page 1336). The limitations “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure; non-natural ---stereoisomer; synthetic composition of matter” does not indicate any structural or manipulative difference. The natural form is capable of having “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure. Further, just because a natural compound may be synthesized, it does not indicate any structural or manipulative difference from its natural form. Thus, limitations, “non-natural ---stereoisomer; synthetic composition of matter” indicate structural or manipulative difference from its natural form.
Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification and the plain meaning of the other terms, the broadest reasonable interpretation of claims is a natural compound and a composition, which also naturally exist comprising the compound. The limitations “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure; non-natural ---stereoisomer; synthetic composition of matter” does not indicate any structural or manipulative difference. The natural form is capable of having “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure. Further, just because a natural compound may be synthesized, it does not indicate and any structural or manipulative difference from its natural form. Thus, limitations, “non-natural ---stereoisomer; synthetic composition of matter” indicate structural or manipulative difference from its natural form. In addition, the steps of the process do not add structural limits to the naturally occurring product. Importantly, the claims are drawn to a product and not to the process and the product occurs naturally and the process provides no patentable distinction from a naturally occurring composition as it is not structurally different compared to its naturally existing form.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Here, the claim recites a composition, which is a statutory category of invention. As explained in the MPEP, it is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the composition is a composition of matter, the claim is to at least one statutory category of invention (Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because the instant claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). Although the limitations “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure; non-natural ---stereoisomer; synthetic composition of matter”, does not indicate any structural or manipulative difference. Thus, the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A). The natural form is capable of having “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure. Further, just because a natural compound may be synthesized, it does not indicate any structural or manipulative difference from its natural form. Thus, limitations, “non-natural ---stereoisomer; synthetic composition of matter” indicate structural or manipulative difference from its natural form. In addition, the steps of the process do not add structural limits to the naturally occurring product. Importantly, the claims are drawn to a product and not to the process and the product occurs naturally and the process provides no patentable distinction from a naturally occurring composition as it is not structurally different compared to its naturally existing form. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). As evidenced by naturally occurring compound 19-norprogesterone that naturally exist in in human/ animal body along with its other isomers ent-19-norprogesterone, stereoisomers, water, enzymes, proteins etc. (i.e., composition), and as evidenced in the instant specification paragraphs 0018-0021 (published instant application):
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Or as evidenced by Casey (J. Clin. Invest. Vol 75, 1985, 1335-1338) (entire article, especially page 1336). Here, the closest natural counterpart is naturally occurring composition present in animals. When the claimed composition from animals is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Therefore, the claimed composition is a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Although the limitations “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure; non-natural ---stereoisomer; synthetic composition of matter”, does not indicate any structural or manipulative difference. Thus, the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A). The natural form is capable of having “concentration-- 23mg---milliliter; delivers –0.05mg/Kg---animal; process limitations (claims 43, 52-63); dosage form limitations (claims 44-50 and 70); molecular weight; molecular formula; chemical structure. Further, just because a natural compound may be synthesized, it does not indicate and any structural or manipulative difference from its natural form. Thus, limitations, “non-natural ---stereoisomer; synthetic composition of matter” indicate structural or manipulative difference from its natural form. In addition, the steps of the process do not add structural limits to the naturally occurring product. Importantly, the claims are drawn to a product and not to the process and the product occurs naturally and the process provides no patentable distinction from a naturally occurring composition as it is not structurally different compared to its naturally existing form. The process steps are at best equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the process of using natural product does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the claims recite additional element of a “intended use of the natural compound”, which is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim(s) 40, 41, 43, 54, 55, 56, 57, 70 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The subject matter of instant claims 40, 41, 43, 54, 55, 56, 57, 70 are not properly described in the application as filed. In particular, there was no indication in original specification as filed of limitations that “concentration of about 23mg---milliliter (40) (has support only in HP-beta-cyclodextrin); delivers at least about 0.05---animal (41); engages progesterone---motor impairment (43); treating for a local or systemic nasal---CNS---disease (54); CNS injury---disorder (55); nasally administered---superior nasal cavity (56); distributed into the subject’s nasal mucosa ----nerve (57); in the form of nanoparticles (70), and therefore raise doubt as to possession of the claimed invention at the time of filing.
Applicant is required to cancel the new matter in the reply to this 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.
Claims 37, 54-63 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 37, 54-63 are indefinite as:
Claim 37 is indefinite as the claim lacks antecedent basis for “The pharmaceutical composition”.
Claims 54-63 are composition claims and recites process. A claim may only be drawn to one statutory category. Applicant is suggested to delete active process steps from the claims. Further, based on restriction/election and applications election of compound and compositions, active process steps are considered only as intended steps.
Appropriate correction required.
Claim Rejections - 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 36-39, 41-50, 52-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmed (Journal of Inclusion Phenomena and Molecular Recognition in Chemistry 30: 111-125, 1998).
Ahmed discloses 19-norprogesterone with all its stereoisomers in solid form with same structure, molecular formula etc. as in the instant claims and composition comprising hydroxypropyl-beta-cyclodextrin carrier in liquid, solution form etc., and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) (entire article).
With regard to limitations “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50” since the cited prior art teaches same composition as in instant claims, the composition of the prior art must be capable of “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Further, the cited prior art teaches same compound having stereoisomers as in the instant claims, the limitations such as nan-naturally occurring, mirror image; molecular weight, molecular formula and synthetic composition of matter carries no patentable weight. Further, compound and composition of the cited prior art is indistinguishable from the instant claims.
Since the cited prior art reads on all the limitations of the instant claims 36-39, 41-50, 52-70, these claims are anticipated.
Claims 36, 37, 41-50, 52-70 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Clive (US 5792757).
Clive disclose 19-norprogesterone and its stereoisomer ent-19-norprogesterone in solid form with same structure, molecular formula etc. as in the instant claims and composition with carrier and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) in solution, topical, solid, powder, suspension form suitable for nasal, oral, topical etc. administration (entire application).
With regard to limitations “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50” since the cited prior art teaches same composition as in instant claims, the composition of the prior art must be capable of “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Further, the cited prior art teaches same compound having stereoisomers as in the instant claims, the limitations such as nan-naturally occurring, mirror image; molecular weight, molecular formula and synthetic composition of matter carries no patentable weight. Further, compound and composition of the cited prior art is indistinguishable from the instant claims.
Since the cited prior art reads on all the limitations of the instant claims 36, 37, 41-50, 52-70, these claims are anticipated.
Claims 36-37, 41-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casey (J. Clin. Invest. Vol 75, 1985, 1335-1338).
Casey disclose 19-norprogesterone with all its stereoisomers with same structure, molecular formula etc. as in the instant claims and composition comprising proteins, enzymes, other neuroprotective compounds etc., and naturally existing in humans and animals (entire article, especially page 1336).
With regard to limitations “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50” since the cited prior art teaches same composition as in instant claims, the composition of the prior art must be capable of “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Further, the cited prior art teaches same compound having stereoisomers as in the instant claims, the limitations such as nan-naturally occurring, mirror image; molecular weight, molecular formula and synthetic composition of matter carries no patentable weight. Further, compound and composition of the cited prior art is indistinguishable from the instant claims.
Since the cited prior art reads on all the limitations of the instant claims 36-37, 41-70, these claims are anticipated.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 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 nonobviousness.
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 36-50 and 52-70 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed (Journal of Inclusion Phenomena and Molecular Recognition in Chemistry 30: 111-125, 1998), Clive (US 5792757) in combination.
Determining the scope and contents of the prior art
Ahmed disclose 19-norprogesterone with all its stereoisomers in solid form with same structure, molecular formula etc. as in the instant claims and composition comprising hydroxypropyl-beta-cyclodextrin carrier in liquid, solution form etc., and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) (entire article).
With regard to limitations “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50” since the cited prior art teaches same composition as in instant claims, the composition of the prior art must be capable of “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Further, the cited prior art teaches same compound having stereoisomers as in the instant claims, the limitations such as nan-naturally occurring, mirror image; molecular weight, molecular formula and synthetic composition of matter carries no patentable weight. Further, compound and composition of the cited prior art is indistinguishable from the instant claims.
Clive disclose 19-norprogesterone and its stereoisomer ent-19-norprogesterone in solid form with same structure, molecular formula etc. as in the instant claims and composition with carrier and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) in solution, topical, solid, powder, suspension form suitable for nasal, oral, topical etc. administration (entire application).
With regard to limitations “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50” since the cited prior art teaches same composition as in instant claims, the composition of the prior art must be capable of “delivers ---0.05mg/Kg---animal; human; intended use process steps of claims 43, 53-63; formulated as of claims 44-50”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Further, the cited prior art teaches same compound having stereoisomers as in the instant claims, the limitations such as nan-naturally occurring, mirror image; molecular weight, molecular formula and synthetic composition of matter carries no patentable weight. Further, compound and composition of the cited prior art is indistinguishable from the instant claims.
Ascertaining the differences between the prior art and the claims at issue
Ahmed disclose 19-norprogesterone with all its stereoisomers in solid form with same structure, molecular formula etc. as in the instant claims and composition comprising hydroxypropyl-beta-cyclodextrin carrier in liquid, solution form etc., and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.), but fails to teach concentration as 23mg/ml.
Clive disclose 19-norprogesterone and its stereoisomer ent-19-norprogesterone in solid form with same structure, molecular formula etc. as in the instant claims and composition with carrier and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) in solution, topical, solid, powder, suspension form suitable for nasal, oral, topical etc. administration (entire application), but fails to teach concentration as 23mg/ml.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference of concentration 23mg/ml in the composition-The cited prior art teaches composition of compound with different carriers. Thus, with the guidance provided by the cited prior art and existing knowledge in the field of chemistry, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that different concentration of compound may be made with other components in the composition depending on desired concentration or ease of making such concentration.
Therefore, combination reads applicants claims.
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ compound and composition.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Ahmed disclose 19-norprogesterone with all its stereoisomers in solid form with same structure, molecular formula etc. as in the instant claims and composition comprising hydroxypropyl-beta-cyclodextrin carrier in liquid, solution form etc., and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) and Clive disclose 19-norprogesterone and its stereoisomer ent-19-norprogesterone in solid form with same structure, molecular formula etc. as in the instant claims and composition with carrier and other stereoisomers or steroids (may also serve as neuroprotective or anti tau etc.) in solution, topical, solid, powder, suspension form suitable for nasal, oral, topical etc. administration. So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that different concentration of compound may be made with other components in the composition depending on desired concentration or ease of making such concentration and can be made by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed composition with a reasonable expectation of success.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 36-70 in the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over the claims 85-98, 150-175, 186-197 of co-pending US application 14857331. Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application are drawn to a compound and a composition comprising the compound and co-pending application is drawn to a process of using compound and a composition comprising the compound of the instant claims. Thus, process of the co-pending application discloses compound and a composition comprising the compound of the instant claims.
The difference, however, does not constitute a patentable distinction, because the claims in the present invention simply fall within the scope of co-pending application. For the foregoing reasons, the instantly claimed compound and composition is made obvious.
This is provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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