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
Claims 1-11 are pending. Claims 1-11 are examined on the merits.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 recites “weeting agent” at line 3, which is incorrect. The correct spelling should be “wetting agent”.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 1-11 is/are directed to a stable topical pharmaceutical composition comprising fertility aid or pharmaceutically acceptable salt thereof and pharmaceutically acceptable excipients.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, an extract of panax ginseng, for example, because there is no indication that extraction has caused the components of an extract of panax ginseng that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components in panax ginseng.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1-11 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claims 1-11, since there is no absolute amounts of the active ingredients are claimed as compared to the whole composition, the claimed composition encompasses embodiments where the active ingredients are in such small amounts that none of them impart any characteristic or markedly different characteristic. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Regarding claims 1-11, the presence of water (a pharmaceutically acceptable excipient, a wetting agent, or a form of solution) in the claimed composition does not result in a markedly different characteristic for the claimed composition because plant materials already comprise water and thus have that same characteristic.
Regarding claim 1, a topical composition does not result in a markedly different characteristic because the process of plant harvest and plant extraction already encompasses contact of plant material to human skin.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claim Rejections –35 USC § 112, 2nd
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 7-10 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 7 recites “The pharmaceutical composition as claimed in claim 1 wherein stable topical pharmaceutical composition provide at least 85 % of Spermatozoa/sperm motility in 20 minute compare to initial Spermatozoa/sperm motility value, at least 55% of Spermatozoa/sperm motility in 120 minute compare to initial Spermatozoa/sperm motility value and at least 35 % of Spermatozoa/sperm motility in 240 minute compare to initial Spermatozoa/sperm motility value.” The recitation is very confusing, the treatment is supposed to increase Spermatozoa/sperm motility, however, claim 7 suggests that the longer the treatment lasts, the more sperms die, for example, after 240 minute’s treatment, 65% of the sperm lost motility. For the same reason, claim 8 indicates treatment lost sperm vitality; claim 9 suggests treatment lost morphology value; claim 10 suggests treatment lost swelling value.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
Claim Rejections –35 USC § 102
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 1-10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Truitt et al (WO 2010083239 A2).
Truitt et al teach a pharmaceutical composition for improving vaginal boundary lubrication through topical administration comprising fertility aid and pharmaceutically acceptable excipients such demulcent, excipient, astringent, vasoconstructor, and emollient (see para 0021, 0026, 0028; claims). Further, it discloses the use of L-arginine as an additive to release nitric oxide [0041]. Moreover, it discloses the use of additional therapeutic agent such as sodium hyaluronate with the pharmaceutical composition (see [007]; claims 19-21). Furthermore, it describes that the topical pharmaceutical composition is formulated in gel (thus a gelling agent, thus claims 5 and 6 are met), cream, salve, solution (thus claim 6 is met), suspension, paste, ointment, spray or the like (thus stable) (see claim 1; [0038]).
Truitt et al teach in some embodiments, any pharmaceutical composition provided herein further comprises one or more additional therapeutic agents selected from the group consisting of sodium hyaluronate (thus the fertility acid, thus claims 2 and 3 are met, thus the molecular weight is high, medium or low, thus claim 4 is met), surface active phospholipids, and electrolytes in a pharmaceutically acceptable carrier for topical administration [0028].
Truitt et al teach in certain embodiments of the present invention provide a personal lubricant that increases the chances of conception by maintaining or increasing the motility of sperm that comes into contact therewith comprised of the application to the vagina, of a patient in need, an effective amount of PRG4 or any pharmaceutical composition described herein [0043].
The intended use of the composition was analyzed for patentable weight. It is deemed that the preamble ‘breathes life’ into the claims in that the prior art product must not be precluded for use to achieve the desired spermatozoa/sperm motility value, vitality value, morphology value, or hypo-osmotic swelling value. It is deemed that the composition disclosed by the cited reference is not precluded for carrying out the intended function of the claims.
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Truitt et al as applied to claims 1-10 above.
The teachings of Truitt et al are set forth above and applied as before.
The teachings of Truitt et al do not specifically teach the claimed process in claim 11.
Regarding the claimed process, the MPEP states the following: "[E]ven though product-by-process claims are limited by and defined by the process determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process...The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product" (see MPEP 2113 [R-1]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add all the claimed components in a vessel, and then stir as one of ordinary skill in the art would have been motivated to do that since that is the well-known practice in the art.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655