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 .
Claims 1-2 & 10-11 remain allowed.
In the response of 3/24/26, applicant dd not amend the claims.
Applicant's arguments have been fully considered but they are not persuasive. Applicant’s argument to all rejections are not commensurate in scope with the claim sin question in that applicant’s arguments all discuss specifics from the specification while the claims do not contain those specifics. Notably, applicant discusses the distinction based on Table 1 of the instant spec but the claims do not require the fractionization of milk as is exemplified and argued.
A showing to overcome a rejection must be clear and convincing( In re Lohr et al. 137 USPQ 548) as well as commensurate in scope with the claimed subject matter ( In re Lindner 173 USPQ 356; In re Hyson, 172 USPQ 399 and In re Boesch et al., 205 USPQ 215 (CCPA 1980).
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 3-9 & 12-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a protein fraction without significantly more. The claim(s) recite(s) a cationic protein fraction. This judicial exception is not integrated into a practical application because claims are drawn to the protein and fraction per se. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to a naturally occurring protein isolated by a specific method but still to the protein and/or fraction that is a naturally occurring protein or combination of naturally occurring proteins, e.g. from milk.
If the culture conditions cause the phenotypic change, then the question is whether or not that change results in something markedly different that a judicial exception:
The specification appears to contain no evidence, that the method of isolating the naturally occurring protein(s) imparts characteristics markedly different from those cells as they exist and function in nature. As such, there is no evidence that the claimed proteins and or fractions have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring proteins and fractions. For these reasons, the claimed invention does not appear to have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception. The claimed invention does not include any additional features that could add significantly more to the exception, so the claim does not qualify as eligible subject matter.
Concluding the analysis, the claimed invention is drawn to a judicial exception to the statute and must be rejected as ineligible under 35 USC101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-9 & 12-18 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 enablement requirement AND the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention or at the time the application was filed, had possession of the claimed invention.
Applicant claims any and all cationic protein fractions without defining a starting solution (even claim 14 indicates that the proteins are “derived from” milk) treating muscle atrophy by administering CD34+ cells and PRP. The claimed invention cannot be considered to be enabled given the limited showing in the specification. First there is no clear reduction to practice of the claimed invention that would be extrapolated to the scope of the instant claims. "Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable .... Tossing out the mere germ of an idea does not constitute enabling disclosure." Genentech Inc. v. Novo Nordisk A/S , 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997).
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
Applicant generically claims any and all cationic protein fractions however the specification does not contain an adequate description for the entire breadth of this limitation and thus the claims. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 3-9 & 12-16 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Kussendrager et al(6010698).
Kussendrager (see esp Ex 1) teaches a cation protein fraction containing lactopperoxidase and lactoferrin from milk. Th fraction is made using ultrafiltration and cation exchange to produce a fraction at pH 6.5 an a conductivity of 2.5mS. While the steps used aren’t identical to those claimed, the resultant fraction contains the same desired proteins and resultant pH.
Note that MPEP § 706.3(e) states that:
"[w]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 35 U.S.C. 102 or 35 U.S.C. 103 of the statute is appropriate. As a practical matter, the Patent and Trademark Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972) ; In re Fessmann, 180 USPQ 324 (CCPA1974)."
Significantly, applicant provides no factual evidence whatsoever to refute the holding of anticipation. Note specifically that on the current record the only way of overcoming such a clear holding of anticipation is factual proof that the rejection is in error. See MPEP § 2112, disclosing that once a proper holding of anticipation is made, the burden shifts to applicant to demonstrate an unobvious difference between the claims and the prior art. See also, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (“the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product”). Because applicant has not demonstrated any difference between the claimed products and the prior art products, the rejection of record clearly must be maintained.
The reference anticipates the claim subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 3-9 & 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussendrager et al(6010698) and EP 0509989 and EP 1409539
Kussendrager (see esp Ex 1) teaches a cation protein fraction containing lactopperoxidase and lactoferrin from milk. Th fraction is made using ultrafiltration and cation exchange to produce a fraction at pH 6.5 an a conductivity of 2.5mS. While the steps used aren’t identical to those claimed, the resultant fraction contains the same desired proteins and resultant pH.
EP 0509989 and EP 1409539 likewise each teach cationic proteins fractions containing ribonucleases and TGF-B fractions.
The references do not specifically teach the exact method of producing the fractions as is claimed however the three references clearly teaches the proteins desired, that they are purifiable using cation exchange and the desire for purity of the proteins and as such the protein per se would have been obvious in a fraction at any desired purity using the known methods in the art for protein purification. Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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