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/Restriction
Applicant’s election without traverse of claims 1, 2-6, and 8 in the reply filed on 03/20/2026 is acknowledged. It is noted that in the restriction requirement, there was a typo in which claim 2 was included the group, however it is cancelled. As such, claims 1, 3-6, and 8 are currently under examination and the subject of the present Office Action. Claims 9-14 and 20 are withdrawn from consideration without traverse.
As such, the restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/26/2024 has been considered here.
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.
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.
Claims 1, 4-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20210227845 A1 (Berg, 2021; as submitted on IDS of 03/26/2024).
In regards to claim 1, Berg teaches a composition in the form of a human milk fortifier or supplement designed for a pediatric subject (see Berg, paragraph 0090) comprising docosahexaenoic acid (DHA) in an amount of 5-100 mg (see Berg, paragraph 0137; Formulation example 1). It is taught that the composition is “nutritionally complete” which means it would supply the daily amounts of vitamins, minerals, and/or trace elements in combination with proteins, carbohydrates, and lipids (see Berg, paragraph 0032). As such the amounts disclosed in Formulation example 1 would be understood to be the daily amount of DHA and other components by one with ordinary skill in the art. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 4-5 and 8, it is taught that the composition comprises vitamin B2, vitamin A, thiamin or thamin monophosphate among other additional components (see Berg, paragraph 0116). More specifically, it is taught that that the composition comprises an eWPC, such as Lacprodan PL-20, in an amount of about 0.5g/L, which comprises about 2.8% of GD3 (i.e., 8.5mg/304mg) (see Berg, paragraph 0066-0067; Table 1). As such, about 2.8% of 0.5g/L of the PL-20 is about 14mg of GD3. “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” One with ordinary skill in the art would reasonably expect that a composition comprising about 14mg of GD3 would have the same properties as a composition comprising 12mg of GD3.
In regards to claim 6, it is taught that the composition is “nutritionally complete” which means it would supply the daily amounts of amounts of vitamins, minerals, and/or trace elements in combination with proteins, carbohydrates, and lipids (see Berg, paragraph 0032). While it is not taught that the composition is provided once daily, it is noted that the amount of drug is clearly a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan. Applicant is advised that recitation of dosages/dosage units, without more, is generally insufficient to patentably distinguish over the prior art.
Berg does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Berg with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 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.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20210227845 A1 (Berg, 2021; as submitted on IDS of 03/26/2024) as applied to claims 1, 4-6, and 8 above, and further in view of US PGPUB 20150064220 A1 (Thomas et al., 2015).
The teachings of Berg have been described supra. Further Berg teaches that the composition comprises eicosapentaenoic acid (EPA), alpha linoleic acid (ALA), and 2-fucosyllactose (2’-FL) (see Berg, paragraphs 0060 and 0080). It is also taught that the 2’-FL is used in an amount ranging from 0.005g/100kcal (i.e., 5mg/100kcal) to about 1g/kcal (i.e., 1000mg/kcal). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Berg is silent on the amount of EPA and ALA used in the composition.
Thomas teaches a composition that is a human milk fortifier or pediatric formula (see Thomas, paragraph 0038) comprising 2’-FL (see Thomas, paragraphs 0026 and 0058), DHA, ALA, and EPA (see Thomas, paragraph 0065). It is taught that the DHA, ALA, and EPA are used in combination in an amount from 0.001g/L to about 1g/L (see Thomas, paragraphs 0065-0068). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 1, 3-6, and 8, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Berg and Thomas to formulate the instant composition as both references are drawn to human milk fortifiers. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, as Berg teaches that the composition comprises ALA and EPA but is silent on their amounts, it would be within the purview of one with ordinary skill in the art to find the amounts known to be used in human milk fortifiers in other references such as Thomas. One with ordinary skill in the art would be motivated to combine the amounts of ALA and EPA of Thomas with the composition of Berg according to the known method of formulating a human milk fortifier (see Thomas, paragraphs 0096-0129) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
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, 3-6, and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 9, and 22-23 of copending Application No. 18695440 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both applications are drawn to a pediatric supplement or human milk fortifier comprising the same compounds in the same amounts.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Isis A Ghali/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
Prosecution Insights