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 .
The amendment filed 1 September 2026 is acknowledged and has been entered.
Status of the Claims
Claims 2, 6, 10, 12-14, 22-24 and 27-33 have been cancelled.
Claims 1, 3-5, 7-11, 15-21 and 25-26 are presented for examination on the merits.
Claim Rejections - 35 USC § 102/103
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:
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.
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, 3-5, 7-11, 15-21 and 25-26 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Elster et al. (US2014/0272027) [cited by Applicant in IDS filed 9/22/23].
Elster et al. describes a human milk cream composition comprising pasteurized cream derived from human milk, wherein the composition comprises about 2.5 kcal/ml, wherein the composition comprises about 25% fat used for enteral nutrition in a low birth weight infant. Elster also describes a method of making a human milk cream composition comprising the steps of: (a) obtaining a pool of human milk, (b) separating the pool of human milk into a cream portion and a skim milk portion (ultracentrifugation), (c) formulating the cream portion to obtain a cream composition comprising about 2.5 kcal/ml, and (d) pasteurizing the cream composition. The results of Elster et al. indicated that infants in the cream test group grew at a faster pace with respect to weight for example to preterm infants with inclusion criteria: birth weight between 750 and 1250 g (less than 3rd percentile); have a reasonable expectation of survival for the maximum duration of the study (through 36 weeks corrected gestational age or weaned from fortification, whichever came first); be able to adhere to a feeding protocol involving mother's own milk/donor milk that will include fortification using Prolact+H<2>MF® and, potentially, human cream; enteral feeding must begin before the 21day of life; informed consent obtained from parent or legal guardian (claims 1-24, Ex.1-2).
The human cream compositions described herein may be used as supplemental nutrition. Accordingly, the human cream compositions described herein may be administered enterally or orally (e.g., bottle feeding) (paragraph 0058).
The disclosed human cream compositions are particularly useful for supplementing human milk for infants, especially LBW infants, in order to raise the caloric content of the human milk to a desired level. Human milk is often administered enterally to preterm infants in the NICU. Enteral nutrition is a practice of tube feeding, e.g., nasogastric, transpyloric, and percutaneous. Human milk (e.g., mother's own or donor) often does not meet the caloric requirements of a LBW infant therefore the human cream composition of the current invention is added to the human milk, thereby increasing the caloric content while also maintaining the entirely human milk diet of the infant and avoiding the complications associated with TPN. In one embodiment, the enteral nutrition comprising the human cream composition is for a preterm or LBW infant (paragraph 0059).
The cited reference does not explicitly disclose treating “failure to thrive”.
As Applicant points out in the instant Specification “[w]hile it may result from various underlying physical or psychosocial causes, failure to thrive generally involves a lack of necessary calories for adequate growth. This could be from not taking in enough calories, losing too many calories, or increased caloric demand”.
Consequently, the claimed method appears to be anticipated by the cited reference.
Alternatively, the instant claims rejected under U.S.C. 103(a) as being unpatentable over Elster et al. (US2014/0272027).
It would have been obvious to one of ordinary skill in the art at the time the effective filing date of the claimed invention to administer the human cream composition to infants in need of caloric supplementation as taught by Elster et al., such as those infants whose weight for age falls below the tenth or fifth percentile on multiple occasions or weight deceleration that crosses two major percentile lines on a growth chart.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
If necessary, the adjustment of particular conventional working conditions (e.g., employing common method of administration, determining the optimal dosage based on desired effect and the individual response of the subject, etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-5, 7-11, 15-21 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,063,943. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are employing the same human milk cream composition and administering it to infants in need of caloric supplementation. In addition, please note that the instant claims encompass and/or are encompassed by the "943 claims.
Response to Arguments
Applicant’s amendments/arguments, with respect to indefiniteness rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of the previous Office action have been withdrawn.
Applicant's amendments/arguments filed with respect to the prior art rejections have been fully considered but they are not persuasive.
Applicant asserts that the methods disclosed by Elster et al. relate, inter alia, to administering a human cream composition to a premature or a low or very low birthweight infant. See Elster et al., paragraphs [0004], [0008], [0016]-[0018], [0050]-[0051], and [0068]-[0099]. Elster et al., uses the terms "premature," "preterm," and "low-birth-weight (LBW)" infants interchangeably to refer to infants born less than 37 weeks gestational age and/or with birth weights less than 2500 g. Elster at al. at paragraph [0020]. The term "very-low-birth-weight (VLBW)" infant refers to an infant with a birth weight of 1250 g or less and is included by the term "low birth weight." Id.
The person having ordinary skill in the art (PHOSITA) would understand that premature/low birth weight and failure to thrive are different conditions and would not consider the conditions equivalent. Prematurity and low birth weight are conditions at birth; prematurity referring to an infant born earlier than 37 weeks gestational age, and low birth weight referring to a low weight at birth. In contrast, failure to thrive relates to inadequate growth relative to expected standards that occurs postnatally. See, e.g., As-Filed Application, paragraphs [0017], [0024], [0103], and [0104]. A premature or low birth weight infant may later develop failure to thrive, but many do not. Likewise, a child may display failure to thrive despite being born at term with a normal birth weight. Thus, the PHOSITA would not consider Elster et al.'s methods of treating premature and low birthweight infants as disclosing treatments for failure to thrive.
Applicant is attempting to distinguish “failure to thrive” from low birth weight, when there is no clear distinction between the two groups and considerable overlap. This is unpersuasive, because one of skill in the art presented with a subject in need thereof (i.e., such as a term infant with lower that normal weight, e.g., a low-birth weight infant) would be in need of supplemental calories, just as those of premature infants, or any infant in need of additional calories. In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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