DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 19, 2025 has been entered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
3. Claim 1 is currently pending.
Claim Rejections - 35 USC § 102
4. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lazaryan (RU 2233666 - translation).
This reference teaches a composition comprising drone brood homogenate. The reference teaches that the drone brood homogenate inherently contains vitamin D (see page 5 of the translation). Thus, the reference teaches a composition comprising drone brood homogenate and vitamin D.
The reference does not specifically teach the same “daily dose” as claimed by applicant. However, claim 1 does not contain a structural requirement for an amount of the drone brood and the vitamin D. Claim 1 states that the composition is a “daily” amount which is considered to be an intended use, i.e. the composition of claim 1 must be capable of being administered in an amount to achieve this “daily" amount. In addition, the reference does not teach that this composition prevents or treats acute respiratory diseases and flu. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Response to Arguments
Applicant's arguments filed March 19, 2025 have been fully considered but they are not persuasive. Applicant argues:
The applicant pointed out that Lazaryan has five active ingredients versus two active ingredients in the applicant’s invention. The USPTO responded that the applicant’s claim uses the transitional term ‘comprising’ and stated, with reference to MPEP 2111.03 - “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps...”.
It follows from this statement that, because of using ‘comprising’, the applicant’s claim could also have five ingredients like Lazaryan. However, such a conclusion would be wrong. First, one can note that Lazaryan also uses the term comprising’, i.e., there ‘can be’ more than five active ingredients in Lazaryan. Second, examination cannot be subjunctive. It must deal with a true picture rather than with a fictitious one, and with what there is rather than with what there could be.
Adding to that, per MPEP 2111, during patent examination, “the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” To suggest that the applicant’s claim could ‘comprise’ additional active ingredients, moving it closer to Lazaryan, would be inconsistent with the specification.
However, applicant’s argument is in direct contrast with the specific guidance of MPEP section 2111. Even if applicant disagrees with the MPEP that does not negate the guidance specifically set forth in the MPEP. If applicant does not wish for the claims to encompass additional ingredients, applicant must amend the claim to a narrower scope such as “consisting essentially of” or “consisting of”.
Applicant also argues:
The FOA also states that though the reference does not teach that this composition prevents or treats acute respiratory diseases and flu, “a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.”
With the above arguments in view, applicant holds, that its claim is structurally different from what Lazaryan discloses, and they present two different products.
However, applicant has not offered any specific evidence to support their assertion that the additional ingredient in Lazaryan make is unsuitable for the intended use. Applicant’s claims state that a composition “comprising” drone brood homogenate and vitamin D are able to prevent and treat acute respiratory disease. If compositions “comprising” these ingredients are not able to function as claimed, then applicant’s claims are arguably not enabled for the full scope claimed. There is no indication that the additional ingredients in the reference, i.e. lactose, pectin, sorbic acid, citric acid, sweeteners, calcium stearate, and aromatizer would render the composition unable to perform the claimed intended use. The reference states that these are tableting ingredients which function as carriers, preservatives, and binders in the tablet (see pages 5). Thus, applicant’s argument is not persuasive.
Claim Rejections - 35 USC § 103
5. Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elistratov (RU 2412616 C1 – English translation) in view of Chatterjee-Kishore (US 2006/0252045).
Elistratov teaches a method for preventing or treating osteoporosis by administering a composition comprising homogenized drone brood. The reference teaches administering between 40 to 1000 mg of the drone brood (see page 2 of the translation).
Elistratov does not specifically teach administering vitamin D in combination with the drone brood. Chatterjee-Kishore teaches that vitamin D supplementation is useful in treating bone loss and osteoporosis (see paragraphs 10, 12, and 901). The reference suggests administering a dosage between 200 and 800 IU (see paragraph 911).
These references show that it was well known in the art before the effective filing date of the claimed the invention to use the claimed ingredients in compositions that treat osteoporosis. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to treat osteoporosis, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat osteoporosis. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach administering the ingredients in all of the amounts claimed by applicant. However, the dosage of a pharmaceutical ingredient is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). The references teach that each of the claimed ingredients is a pharmaceutically active ingredient. An artisan of ordinary skill would routinely modify the amount of pharmaceutically active ingredients based on the patient's age, weight, gender, and condition. Therefore, an artisan would have been motivated to modify the dosage of each ingredient in the combination in order to formulate a product that best achieves the desired results set forth in the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage amount would have been obvious at the before the effective filing date of the claimed invention.
The references do not teach that this composition had the same intended uses as claimed. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Response to Arguments
Applicant's arguments filed March 19, 2025 have been fully considered but they are not persuasive. Applicant argues:
It follows from the above that by ‘the field of the inventor’s endeavor’ MPEP understands ‘the particular problem with which the inventor was concerned .
The particular problem (problem 1) with which the inventor[s] is [are] concerned is preventing and treating acute respiratory diseases and flu.
On the other hand, the particular problem (problem 2) with which the Elistratov reference is concerned is preventing osteoporosis, and the particular problem (problem 3) with which the Chatterjee reference is concerned is compositions, compounds, apparatuses and methods of using them to study bone mineralization and identify agents that regulate bone mineralization.
It is visible to the naked eye that problems 1 and 2-3 differ from each other.
On top of all that, the Elistratov reference is classified under A23L which relates to Foods or food stuffs, rather than pharmaceutical compositions mentioned by the FOA.
It turns out that the person skilled in the art found the Elistratov reference not because it relates to the above problem 1, with which the inventors are concerned, and not even because it belongs to pharmaceutical compositions, as the FOA asserts, but seemingly because — and the FOA itself frankly discloses it — the reference comprises same ingredient as claimed — drone brood.
In a similar fashion, the Chatterjee reference, which is classified under C12Q (Measuring or testing processes involving enzymes, nucleic acids or microorganisms) appears to have been cited for the same reason.
However, the information about claimed ingredients is not available to outsiders by default, and if it is used by a person skilled in the art, an outsider, it may only be the result of taking it from the applicant’s disclosure which is inadmissible.
However, MPEP section 2141.01(a-I) states that art can be used in a 103 rejection if the art is in the same field of endeavor even if the reference addresses a different problem. The references are in the same field of endeavor as the claimed invention because they are drawn to pharmaceutical compositions with the same ingredients as claimed. The assumption is that an artisan of ordinary skill would be aware to research in the same field of endeavor. Thus, even if applicant disagrees with the MPEP that does not negate the guidance specifically set forth in the MPEP. Furthermore, references do not have to share the same classification to be considered relevant prior art. Thus, applicant’s arguments are not persuasive.
Double Patenting
6. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,827,273 for the reasons set forth in the previous Office action.
7. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 6 of copending Application No. 15/796,734 (reference application) for the reasons set forth in the previous Office action.
8. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 14/395,482 (reference application) for the reasons set forth in the previous Office action.
Applicant has requested that these rejections be held in abeyance until allowable subject matter is indicated. The request is noted. The rejections are currently still considered valid at this time for the reasons set forth in the previous Office action.
9. No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655