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 .
Claim Objections
Claims 1, 4, 5, 10, and 21 are objected to because of the following informalities: lacto-N-neotetraose is not a proper noun and therefore the first letter need not be capitalized.
Claim 5 is objected to because of the following informalities: in line 3, a colon should follow “of”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11-15 recite the “method according to claim 10 for use in …”, it is noted that these claims do not further recite an active step relating to the “for use…” phrase. Therefore the phrases do not further limit claim 10. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1, 3-5, 9-15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Binia (WO 2019008104A1; citations are to US 2020/0305488).
Binia teaches a milk composition “for use to supplement the breast milk produced for an infant of up to 1 month of age by a mother who has given birth by C-section”, comprising 400 mg of 2-fucosyllactose (2’-FL) per 2g package (Example 3, Table XV; see title; abstract; paras.0008-20, 0036-110). Binia further teaches including lacto-N-neotetraose (LNnT) at 22-650 mg/L, e.g. 43 mg/L (para.0064, Table III). Milk fortifier compositions in Examples 2 and 4 further comprise all of the components in claim 3, with the ratio of ALA to DHA to EPA, per 100 kcal (107.1 : 37.26 : 4.06) overlapping that in claim 3 (19-80 : 13-25 : 6-9).
Binia does not specifically teach the amounts respectively as “a daily amount”. However Binia discusses using its milk fortifier for preterm infants and those of low birth weight ranging from under 1000g to over 2500g (paras.0017, 0038, 0041-48). The person of ordinary skill in feeding infants would know that feeding volume depends on the infant’s weight as a primary factor, and the skilled person thus could optimize within Binia’s guidelines. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding 11-15 which recite the “method according to claim 10 for use in …”, it is noted that these claims do not further recite an active step relating to the “for use…” phrase and further to the “administering” in claim 10. Therefore the phrases do not further limit claim 10. Also the following is noted:
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
(B) "adapted to" or "adapted for" clauses,
(C) "wherein" or "whereby" clauses,
(D) contingent limitations,
(E) printed matter, or
(F) terms with associated functional language.
This list of examples is not intended to be exhaustive... For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05.
MPEP §2103(I)(C) (emphases added). Here the phrases “for use in preventing sub-optimal growth and development”, for example in claim 11, does not require the particular structure, e.g., the specific components in claim 10, to obtain the result of “preventing sub-optimal growth and development” recited in the clauses. Thus the phrases do not limit the scope of claim 10, and are not afforded patentable weight. Moreover a clause that “simply expresses the intended result of a process step positively recited” in a method claim is not given weight. MPEP §2111.04(I)(citations omitted). It is further noted that Binia discusses aspects of the “for use…” in claims 11-15, e.g., preventing sub-optimal intake of a human milk oligosaccharides, etc. (see, e.g., paras.0089, 0094).
Regarding claim 21, Binia’s Example 1 (paras.0111-39; see para.0008) specifically shows identification of nutrient gap among milks from mothers who had given vaginal or Caesarean births.
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, 9-15, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 8, and 16 of copending Application No. 16/628735 (reference application) in view of Binia (EP 3648617A1; citations are to US 2020/0305488).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to methods of supplementing milk for an infant born via Caesarian section, comprising administering 2’-FL and LNnT. The ‘735 application claims 8-10,000 mg/L of 2-fucosyllactose and 0.1-700 mg/L of LNnT, whereas the present claims recite a daily amount range. However Binia teaches a milk composition “for use to supplement the breast milk produced for an infant of up to 1 month of age by a mother who has given birth by C-section”, comprising 400-10000 mg/L 2’-FL and LNnT at 22-650 mg/L, e.g. 43 mg/L (para.0064 Table III; see title; abstract; paras.0008-20, 0036-110). Therefore the skilled person would have been motivated to optimize the concentrations of both 2’-FL and LNnT within the guidelines of Bini and an infant’s body weight to arrive at a suitable daily amount range. Optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-5, 9-15, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-14 and 20 of copending Application No. 18/695455 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a pediatric supplement or human milk fortifier comprising identical ingredients and method of using the same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/ Primary Examiner, Art Unit 1614